(1) Field Of The Invention
This invention relates generally to baby-food compositions and, more particularly, to novel baby-food compositions comprising ginger and to methods of making and using the compositions.
(2) Description Of The Related Art
Gastroesophageal reflux is the passive regurgitation of gastric contents into the esophagus, often manifested in infants as the "spitting up" of milk. (Forfar and Arneil's Textbook of Pediatrics Fifth Ed., Campbell and McIntosh, Eds., Churchill Livingstone, N.Y., pp 427-428). This condition is distinctly different from vomiting, which is an active process that requires the contraction of the diaphragm and abdominal muscles to initiate the event (id.).
Although the lower esophageal sphincter functions to prevent reflux of gastric contents into the esophagus, gastroesophageal reflux is known to be a physiological phenomenon occurring occasionally in all individuals during postprandial periods (Glassman et al., Gastrenterol. Clin. N. Amer. 24:71-98, 1995). Gastrointestinal reflux is particularly common in children and it can sometimes be a problem when associated with an incompetent or, in the case of infants, an immature lower esophageal sphincter (Nelson Textbook of Pediatrics, 15th Ed., Nelson, Ed., Saunders Co., 1996, pp 1055-1056). Nevertheless, regurgitation or "spitting up" often resolves with maturity. (Id.).
The majority of infants have minor degrees of reflux and this is accepted by most caregivers as being a normal, although sometimes inconvenient feature of infancy. However, inexperienced or stressed caregivers may have difficulty coping with the problem. Furthermore, in some infants, significant reflux occurs associated with complications such as esophagitis, aspiration or failure to thrive (Forfar and Arneil's Textbook of Pediatrics Fifth Ed., supra).
The particular approach used in dealing with gastroesophageal reflux depends upon the severity of symptoms. (Killeen, Advance for Physician Assistants June 1997; Forfar and Arneil's Textbook of Pediatrics Fifth Ed., supra; Nelson Textbook of Pediatrics, 15th Ed., supra). With mild to moderate reflux, the infant can be kept prone or with the head raised in bed. Dietary changes such as thickening the infant's formula with cereal can also be used.
Where simpler measures fail to reduce the reflux, pharmaceutical treatments are sometimes used including the use of prokinetic agents or drugs that increase gastric pH (Forfar and Arneil's Textbook of Pediatrics, Fifth Ed., supra; Killeen, Advances for Physician Assistants, supra). The prokinetic agents increase gastric emptying and esophageal motility along with lower esophageal sphincter pressure. Drugs that increase gastric emptying, esophageal motility and lower esophageal sphincter pressure include metoclopramide (Therapeutic Drugs, Dollery, ed., Churchill Livingston, N.Y., 1991, pp. M148-152), domperidone and cisapride (Forfar and Arneil's Textbook of Pediatrics, Fifth Ed., supra). Drugs that increase gastric pH include histamine H-2 receptor blocking drugs such as cimetidine or ranitidine and proton pump inhibitors such as omeprazole (id.). All of these drug treatments, however, have the potential of producing undesirable side effects.
Ginger is the rhizome of the plant Zingiber officinale. Ginger is a commonly used spice which exhibits a characteristic aroma and mild pungency both of which contribute to the flavor of ginger. Ginger contains volatile aromatic oils referred to as essential oils, which are largely responsible for the aroma of ginger; pungent compounds which make up the solvent extractable oleoresins in addition to the essential oils and which are largely responsible for the pungent flavor of ginger; and starch, proteins and other substances (Govindarijan, CRC Crit. Rev. in Food Sci. and Nutr. 17:1-96, 1982). In addition to its common usage as a spice in the dried and ground form, ginger has been shown to relieve nausea and vomiting associated with a number of conditions including nausea and vomiting in pregnant women (Fischer-Rasmussen et al, Europ. J Obstetrics & Gynocol and Reprod Biology 38:19-24, 1990), in motion sickness (Grontved et al., ORL 48:282-286, 1986; Grontved et al., Acta Otolaryngol (Stockh) 105:45-49, 1988; Holtman et al, Acta Otolaryngol (Stockh) 108:168-174, 1989; Mowery et al, Lancet Mar. 20, 1982; Schmid et al, J Travel Med 1:203-206), in the postoperative setting (Phillips et al. Anaesthesia 48:715-717, 1993) and in chemotherapy-associated nausea and vomiting (Conlin, Dissertation Abstr. Intl. 47:3297B, 1987). The mechanism of this antiemetic action of ginger is unknown although both a local effect on the gastrointestinal tract (Holtmann et al, Acta Otolaryngol 108:168-174, 1989) and a central action (Lumb, Anaesthesia 48:1118, 1993) have been proposed. All of these earlier studies dealt with nausea and vomiting which as noted above are distinctly different conditions than gastroesophageal reflux and none of the reports provided any suggestion as to whether ginger might be useful in relieving gastroesophageal reflux.
The pharmacologic effects of ginger have also been studied and one report has indicated that ginger root extracts, i.e. oleoresin components, increase gastrointestinal motility following oral administration (Yamahara et al, Chem Pharm Bull., 38: 430-431, 1990; Kasahara et al, Shoyakugaku Zasshi 37:73, 1983). This effect would appear to have been due predominantly to an increase in intestinal motility inasmuch as it has been reported that ginger powder does not affect gastric motility or gastric emptying rate (Phillips et al, Anaesthesia 48:393-395, 1993).
Ginger has been suggested for use in indigestion in adults. Although ginger is generally recognized as safe by the U.S. Food and Drug Administration (21 C.F.R. .sctn. 182.1), nevertheless, ginger is, in general, not used in infants as a result of its spicy, intense character (see, for example, Landis in Herbal Defense, Warner Books, Inc., N.Y., 1997, p. 255). Thus, there remains a continuing need to develop for a safe and effective approach to relieving gastroesophageal reflux in babies.